Blood Transfer Accessory (BTA)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SafetiCET Safety Lancet

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SafetiHeel, MediHeel, Novaplus

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC

FDA 510(k)

FDA Class 2 ·Hematology

SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN

FDA 510(k)

FDA Class 2 ·Hematology

SMART Bun-Yo-Matic X-Ray

FDA 510(k)

FDA Class 2 ·Radiology

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NAV PAK Needle, NIM NAV PAK Needle

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SMART Bun-Yo-Matic CT

FDA 510(k)

FDA Class 2 ·Radiology

HawkOne Directional Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vivid E80, Vivid E90, Vivid E95

FDA 510(k)

FDA Class 2 ·Radiology

Venue Fit

FDA 510(k)

FDA Class 2 ·Radiology

Venue

FDA 510(k)

FDA Class 2 ·Radiology

PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II

FDA 510(k)

FDA Class 2 ·Hematology

AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BEST PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Bonelogic

FDA 510(k)

FDA Class 2 ·Radiology

SmartTarget

FDA 510(k)

FDA Class 2 ·Radiology

ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT

FDA 510(k)

FDA Class 2 ·Hematology